Tag Archives: Tylenol

The Thorny Issues in a Product Recall

In 1982, people in Chicago began dropping dead from cyanide poisoning, which was linked to Johnson & Johnson’s Tylenol in select drug stores. Johnson & Johnson immediately pulled all Tylenol from the shelves of all stores, not just those in Chicago. It was ultimately determined that the product had been tampered with by someone outside of Johnson & Johnson. But the company’s aggressive actions produced a legend: The Tylenol scare was chalked up as the case to review for an effective brand-preserving (even brand-enhancing) product recall strategy.

In 2011, though, the FDA took the extraordinary step of taking over three Johnson & Johnson plants that produced Tylenol because of significant problems with contamination. This time, Johnson & Johnson could not blame a crazed killer, only itself. A company that should have learned from its own celebrated case study had not retained that knowledge 30 years later.

The problems associated with recalls often aren’t the recall itself. In a recall, stores pull the products, and the media helps get the message to those who have already purchased the product to return them for refunds, replacement, repair or destruction.

One problem crops up when companies are too slow to move. It was revealed in the press in June 2014, that GM allegedly knew of its ignition switch problems seven years before it recalled the product. The recall that began in February 2014 itself became tortuous as new models were added almost daily to the list of cars that were in danger of electrical shutdown while in motion. The press, the regulators and, of course, the lawyers pounced on GM for its alleged withholding of information for so long and for the seemingly endless additional recall of cars affected by the problem. In 2015, regulators have called meetings with GM and other auto manufacturers mired in what has become an epidemic of recalls to discuss why repairs are dragging on so long.

Denial, lack of information, hunkering down (bunker mentality), secrecy, silo mentality and fears for the impact on the bottom line all contribute to disastrous recalls. With all recalls, there is the cost of the recall, the cost of complete or partial loss or loss of use of certain products, repair costs in some cases (GM), regulatory scrutiny and fines, class action and other lawsuits and the loss of potential income during any shutdown. These can all be big-ticket items, and some companies will not survive these expenses and loss of revenue.

Probably the biggest cost of any recall is the cost to reputation, which can mean loss of existing and future customers. In recent years, lettuce growers and a peanut warehouse did not survive recalls over contaminated products. In the case of primary agricultural producers like growers and peanut warehouses, the processors simply change suppliers, leaving the primary producers without any customers. In the retail market, the competition for shelf space is high. Brands that are recalled that are new or that do not have high customer value are simply barred from shelf space, effectively destroying the ability to market their products.

However, there are others that have strong brand following and even cult-like status in local markets. Blue Bell Creameries (famous for its ice cream) is one such company that has secured an almost cult-like following in the Southern and Midwestern states. Blue Bell, founded in 1907, maintains its headquarters in the small town of Brenham, TX (pop. 16,000).

Problems began when hospitals in Arizona, Kansas, Oklahoma and Texas reported patients suffering from an outbreak of listeria-related diseases, some as early as 2010. Some reports included the deaths of patients. On May 7, the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) reported, “It wasn’t until April 2015 that the South Carolina Department of Health and Environmental Control during routine product sampling at a South Carolina distribution center, on Feb. 12, 2015, discovered that a new listeria outbreak had a common source, Blue Bell Chocolate Chip Country Cookie Sandwich and the Great Divide Bar manufactured in Brenham Texas.”

Listeria is a bacteria that can cause fever and bowel-related discomfort and even more significant symptoms, especially in the young and elderly. Listeria can kill. Listeria is found naturally in both soil and water. Listeria can grow in raw and processed foods, including dairy, meat, poultry, fish and some vegetables. It can remain on processing equipment and on restaurant kitchen equipment, and when food comes in contact with contaminated equipment the bacteria finds a ready-made food source in that food and multiples. The FDA has issued guidance reports to food processors, preparers and restaurants on how to prevent listeria contamination. This includes proper preparation techniques, cleaning techniques, hygiene, testing and manufacturing and processing methodologies.

Once Blue Bell understood that its cookie sandwiches and ice cream bars were implicated, the company immediately recalled the products. But soon it became evident to Blue Bell and others that this outbreak might not be limited to the ice cream bars or cookie sandwiches, and Blue Bell recalled all of its product and, to its credit, shut down all manufacturing operations.

The FDA conducted inspections of Blue Bell plants, and in late April and early May produced reports on three plants, noting issues of cleanliness and process that were conducive to listeria growth. The FDA has also reported that Blue Bell allegedly had found listeria in its plants as far back as 2010 but never reported this to the FDA.

As of this writing, Blue Bell plants are still shut down. The FDA investigation has come to a close, but many questions remain. The company has cut 1,450 jobs, or more than a third of its work force, and has said it will reenter the market only gradually, after it has proved it can product the ice cream safely.

The question is whether these things Blue Bell has done: the quick recall, first of the problem products and then all products, and the closure of plants to mitigate contamination issues are enough to save Blue Bell from further damage in the eyes of consumers and the stores that sell the product. There are many tough questions to be answered going forward.

In the intervening months, will competitors replace Blue Bell with their own products that consumers feel will compare favorably? If so, when Blue Bell products are returned to stores will consumers return, or has the stigma of listeria and the acceptance of the taste of comparable products weakened the brand? Will stores give Blue Bell adequate shelf space? And, does Blue Bell have enough of a cult following and viral fan base that once product is back in stores customers will return as if nothing had happened? These are the scary questions that affect all food and drug companies when recalls are from contamination in their own plants or those in their supply chain.

The American consumer seems to have become numb to the endless succession of automobile recalls from just about all manufacturers. We dutifully return our vehicles to the dealer to fix a broken or faulty this or that. Even though many recalls involve parts or processes that could cause car accidents, injuries and deaths, it is as if we have come to accept faulty auto products as the norm.

This is not the case with food-borne illnesses. The fact that a faulty car can kill as easily as a contaminated food product seems not to be an issue as people return again and again to buy new cars from the same car manufacturer that issued five recalls on their last purchased model. However, consumers will shun the food brand that made some people ill. This bifurcated approach to risk makes no sense even in the context of protecting children from harm. The faulty car that mom drives the kids around in every day may have the same probability of injuring or killing her child as the recalled food brand. She doesn’t abandon her car, but she bans the recalled food brand from her table.

In 1990, Perrier discovered benzene in its sparkling water product. It quickly recalled all its product but then hunkered down into a bunker mentality. The lack of communication by Perrier about the problem and what it was doing exacerbated the fears of consumers, and the press speculation and outcry ran high. Perrier had always touted the purity of its water, so toxic benzene shattered this claim. Hunkering down reduced consumer confidence, and many left Perrier for suitable alternative products. Perrier has never regained the market share it had previously.

Blue Bell has taken the time to do things right, to find the causes of the problem and take steps necessary to prevent contamination in the future. But time also means that existing or even new competitors with comparative products will try to fill the shelf space vacated by Blue Bell’s absence. You can be sure that other-region favorites with cult followings that could never before gain a foothold in Blue Bell’s territory have been pressuring retailers to try them out as a replacement for Blue Bell.

Is the Perrier loss of market share inevitable for Blue Bell even if Blue Bell communicates adequately and with transparency? Time will tell. For now, Blue Bell not only has to fix the problems of plant cleanliness, it also needs to address emerging questions about its past operations, such as allegedly not reporting to the appropriate

While we note the good press that surrounded the 1982 Tylenol (external-tampering) recall and have seen so far a good effort by Blue Bell to resolve its own plant contamination issue, ultimately it is contamination that is the problem. Companies can become complacent, let cleanliness slide, use outmoded procedures, not replace older equipment or even ignore warning signs and isolated contamination events. Regional and limited product line companies need to be especially cognizant that even though they have carved out a powerful niche in the marketplace, maintaining this niche is tenuous at best in the highly competitive world of food products. Cleanliness and contamination-free are assumed by consumers. Food processors and manufacturers must do everything possible to keep that assumption from becoming contradicted.

5 Personal Traits of Great Leaders

Many C-suite insurance executives complain about how difficult it is to find leaders in their organization. Many people believe leadership can’t be taught. “You know it when you see it” is a common observation. Finding a consistent definition for leadership is difficult.

How do you develop/teach/articulate a core set of traits of great leaders if it is so difficult to even define leadership? After leading various organizations ranging in size from several people to several thousand, I realize that there are fundamental core requirements needed to be an effective leader. Whether you are an entry-level employee or the chief executive of a large organization, you need these characteristics to lead.

Leadership doesn’t come from your title. It comes from how you act. People follow leaders; they don’t follow titles. As technology allows companies to be leaner, and as Millennials become a bigger part of the work force, we live in a less hierarchical and more collaborative work environment. Leadership no longer comes with a title. Today, companies need leaders at every level.

You don’t need to be outgoing or have the loudest voice in the room. People with low-key personalities can also be outstanding leaders. Personal leadership is not about self-promotion; leadership is the ability to get others to follow what you are advocating. To trust you. To respect you. To feel that your direction and requests are in everyone’s best interests, not just your own.

So what are the traits of great leaders? Here are five core personal leadership competencies that anyone must practice to be an effective leader.

1.         Integrity: Make sure you do the right thing for all the right reasons. In any leadership role, you will be called on to make difficult decisions. If you act with integrity, you will be respected. People might disagree with your decision, but they will accept your direction. One of my mentors told me, “People can spot someone who takes moral shortcuts.” Never forget: A reputation lost is a career destroyed.

2.         Courage: All leaders have courage. The courage to ask why. To challenge the status quo. To go out on a limb. To do what others are afraid to say and do. Many years ago, when  eight bottles of Tylenol were found to have been tampered with, leading to seven deaths from cyanide poisoning in the Chicago area, the CEO of Johnson & Johnson, which produced Tylenol, immediately directed that all bottles of the pain reliever be removed from every shelf in every store. He vowed that Tylenol wouldn’t be back on store shelves until the company knew that every bottle was safe. It was a bold move with a large negative impact on the company’s short-term sales. But when Tylenol did return to the counters and shelves, so did their customers.

3.         Lead by example: Don’t ask anyone to do something you wouldn’t do yourself. If you are asking others to stay late, you had better, too. When I ran a new business unit, our initial office space couldn’t accommodate an office for everyone. So I sat down with my senior team, and we defined objective criteria for an office. I didn’t qualify, and, much to everyone’s surprise, I sat in a cubicle alongside the other employees. It made a statement — I play by the same rules as everyone else. Likewise, any rule or policy we adopt, I make sure I also abide by. You can’t act one way and expect others to act differently. You have to be a role model.

4.         Be a great listener: You can’t understand what’s going on around you unless you listen to others. Listening is how you learn. Listening is how you gain perspective. Listening is how you understand what’s important and what’s not. Listening is how you discover opportunities. A good listener sends a strong message to others: “I respect and care about what you say. I’m not a tyrant.” Throughout my career, the best ideas always came from people closest to the core operations I was looking to improve. You can’t find those answers unless you ask a lot of questions and listen carefully to the answers.

5.         Be a great communicator: Leaders learn to master the form and substance of communication.

Let’s start with the form of communication: the way you communicate. You can’t lead unless people understand you. Language, tone, facial and other physical expressions all send messages that affect what you are saying. (This also applies to listening. If you look away while people are talking they know you are not listening.) Here are a few tips to master good communication form:

  • Keep your message clear and concise. We live in a world of short attention spans. People get drawn away quickly. Spend time thinking about what you want to say and how best to communicate it quickly. I like to pretend I only have 30 to 60 seconds to talk. That forces me to get right to the point.
  • Use examples. They reinforce your points by tying them to real life instead of dry theories.
  • Think like a teacher. Great communicators understand that, when they are speaking to someone or to a group, they are in effect teaching others what they want them to understand.

Mastering the substance of communication means the ability to move people to react to what you are saying in the way you want. In other words, you want your words to motivate, educate and inspire.  By motivate, I mean the ability to get people to want to do something as a result of what you say. Your words ignite your listener to want to react in the way you desire. Educate means you explain why you are asking them to do something. People will follow direction — but only grudgingly if they don’t understand why they are being asked to do something. Good leaders know how to get people to understand why they should take a specific action. Inspire means the ability to touch someone with your words. Engender a positive emotion that enables them to do something they otherwise might not have done.   Inspirational leaders provide the fuel to allow others to find success.

Today’s ever-changing work environment is creating opportunities for people at all levels of an organization to lead. Those who master the personal leadership competencies that I’ve described will enrich their work experience and create wonderful opportunities for themselves and others. Enjoy the journey.

When Is It Right to Prescribe Opioids?

Opioids have been used for thousands of years in the treatment of pain and mental illness. Essentially everyone believes that opioids are powerful pain relievers. However, recent studies have shown that taking acetaminophen and ibuprofen together is actually more effective in treating pain. Because of this, it is helpful for medical professionals and patients to understand the history of these opioid medications and the potential benefits of using nonsteroidal anti-inflammatory drugs (NSAIDs) instead.

Extracted from the seedpod of the poppy plant, opium was the first opioid compound used for medicinal purposes. The active ingredients of opium are primarily morphine, codeine and thebaine. Opium and its derivatives have had more impact on human society than any other medication. Wars have been fought and countless lives have been lost to the misuse, abuse and overdose of opioids. It is also clear, however, that many received comfort from pain when there was no other alternative. For thousands of years, opium products provided the only effective treatment of pain and were also used to treat anxiety and depression. Tolerance, dependence and addiction were identified early as a problem with opioids.

In 1899, Bayer produced and introduced aspirin for wide distribution. It became the first significant alternative to opioids for treating pain. Aspirin not only relieves pain but also reduces inflammation and is in the class of NSAID medications. Aspirin was commonly used for mild pain such as headache and backache. Other NSAID medications followed with the development of ibuprofen in 1961, indomethacin in 1963 and many others over the next 20 years. While these drugs are not addictive or habit-forming, their use and effectiveness were limited by side effects and toxicity. All NSAID medications share some of the same side effects of aspirin, primarily the risk of gastrointestinal irritation and ulcer. These medications can also harm renal function.

Acetaminophen was created in 1951 but not widely distributed until 1955 under the trade name Tylenol. Acetaminophen is neither an opioid nor an NSAID. Tylenol soon became another medication that was useful in the treatment of pain, offering an alternative to the opioid medications and to aspirin. Acetaminophen avoids many of the side effects of opioids and NSAIDs b­ut carries its own risk with liver toxicity.

Efficacy in acute pain

Since the development of acetaminophen, medical professionals have had the choice of three different classes of medications when treating pain. Those decisions are usually made by considering the perceived effectiveness of each medicine and its side effects along with the physical status of the patient. For example, acetaminophen should not be taken by someone with advanced liver damage; NSAIDs should not be given to an individual with advanced kidney disease or stomach ulcers; and opioids pose a potential risk to anyone with a personal or family history of addiction.

Although many have long been believed that opioids are the strongest pain medications and should be used for more severe pain, scientific literature does not support that belief. There are many other treatments that should be utilized for treating pain. Studies have shown NSAIDs are just as strong as the opioids.

Number needed to treat

When considering the effectiveness or the strength of pain medications, it is important to understand one of the statistical measures used in clinical studies: the number needed to treat (NNT). NNT is the number of people who must be treated by a specific intervention for one person to receive a certain effect. For example, when testing pain medications, the intervention is the dose of pain medication, and the effect is usually 50% pain relief. That is considered effective treatment, allowing people increased functional abilities and an improved quality of life (Cochrane. org, 2014). So the question becomes, how many people must be treated with a certain dose of a medication for one person to receive 50% pain relief (effective relief)?

A lower NNT means the medicine is more effective. A product with an NNT of 1 means that the medicine is 100% effective at reducing pain by 50% — everyone who takes the medicine has effective pain relief. A medicine with an NNT of 2 means two people must be treated for one to receive effective relief. Or, alternatively, one out of two, or 50%, of people who take the medicine get effective pain relief. An example of a medicine that would not be a good pain reliever would be one with a NNT equal to 10. In such a case, you would have to treat 10 people for one to receive effective pain relief. Basically, the medication with the lowest NNT will be the most effective. For oral pain medications, an NNT of 1.5 is very good, and an NNT of 2.5 would be considered good.

Treating chronic pain

Despite the widespread use of opioid medications to treat chronic pain, there is no significant evidence to support this practice. A recent article reviewing the evidence regarding the use of opioids to treat chronic non-cancer pain concluded, “There is no high-quality evidence on the efficacy of long-term opioid treatment of chronic nonmalignant pain.” (Kissin, 2013, p. 519) A recent Cochrane review comparing opioids with placebo in the treatment of low back pain came to a similar conclusion. This review said that there may be some benefit over placebo when used for short-term treatment, but no evidence shows that opioids are helpful when used for longer than four months. There is no evidence of benefit over non-opioid medications when used for less than four months. (Chaparro et al., 2014)

Several other reviews have also concluded that no evidence exists to support long-term use – longer than four months – of opioids to treat chronic pain. (Kissin, 2013; Martell et al., 2007; McNicol, Midbari, & Eisenberg, 2013; Noble et al., 2010)

Epidemiologic studies have also failed to confirm the efficacy of chronic opioid therapy (COT) for chronic non-cancer pain. A large study from Denmark showed that those with chronic pain who were on COT had higher levels of pain, had poorer quality of life and were less functional than those with chronic pain who were not on COT. (Eriksen, Sj.gren, Bruera, Ekholm, & Rasmussen, 2006)

In the last 20 years in the U.S., we have increased our consumption of opioids by more than 600%. (Paulozzi & Baldwin, 2012) Despite this increase, we have not decreased our suffering from pain. The Burden of Disease study in the Journal of the American Medical Association (JAMA) showed that Americans suffered as much disability from back and neck pain in 2010 as they did in 1990 before the escalation in the prescribing of opioids. (Murray, 2013) A study in JAMA in 2008 found, “Despite rapidly increasing medical expenditures from 1997 to 2005, there was no improvement over this period in self-assessed health status, functional disability, work limitations or social functioning among respondents with spine problems.” (Martin et al., 2008, p. 661)

It is currently estimated that more than 9 million Americans use COT for the treatment of chronic nonmalignant pain (Boudreau et al., 2009). When we consider the proven benefits of this treatment along with the known risks, we must ask ourselves how we can ethically continue this treatment.

The reality is we really don’t know if COT is effective. Anecdotal evidence and expert opinion suggest it may be beneficial in a few, select people. However, epidemiologic studies suggest that it may be doing more harm than good.

Terminal care

The treatment of incurable cancer, end-stage lung disease and other end-of-life situations are notable examples where opioid medications are absolutely indicated. Although opioid painkillers are not very good medications for the treatment of pain, they are very strong psychotherapeutic agents. They are excellent at relieving anxiety and treating depression for a limited time. Opioids cause beneficial changes to brain serotonin, epinephrine, norepinephrine, dopamine and endorphins. For short-term, end-of-life situations, these neuropsychiatric effects are likely beneficial. For terminal care, opioids are the medications of choice.

Conclusion

The opioid medications are often referred to as “powerful painkillers.” In fact, the evidence shows that they are mild to moderate painkillers and less effective than over-the-counter ibuprofen. They have, however, powerful side effects that harm hundreds of thousands of individuals every year in the U.S. Even if one disregards the public health problems created by the use of opioid painkillers, these medications still are not a good choice for the treatment of acute pain — regardless of the severity. In some situations, limited use is appropriate. But in the majority of situations in which opioid painkillers are used today, they are not appropriate.

The standard of care in the practice of medicine today is to provide the best treatment that causes the least harm. When there is a treatment that is proven to be both more effective and safer, it is the treatment of choice. The implication of this data for policymakers is critical. By implementing policy that puts restrictions on opioid prescribing to protect public health, policymakers will also improve the treatment of pain by guiding prescribers to use medications that are more effective. It is also important for the medical and dental communities to address this inadequate and unsafe treatment of pain and change practice standards to guide care that is more appropriate for what our patients need and deserve.

This is an excerpt from a paper that can be downloaded in its entirety from the National Safety Council.